Aldeyra Therapeutics, Inc. announced its intent to submit to the US Food and Drug Administration (FDA) a Formal Dispute Resolution Request (FDRR) for reproxalap, an investigational drug candidate for the treatment of dry eye disease. The FDRR, which is expected to be reviewed by the FDA’s Office of New Drugs (OND), is designed to appeal the March 16, 2026, complete response letter that denied approval of a new drug application (NDA) for reproxalap for the treatment of dry eye disease. Submission of the FDRR and a meeting with the OND are expected in the fourth quarter of 2026, the company said in a press release. 

Following 1 NDA submission and 2 NDA resubmissions of reproxalap for the treatment of dry eye disease, Aldeyra has received 3 complete response letters, the first 2 of which recommended an additional clinical trial to “demonstrate a positive effect on the treatment of ocular symptoms of dry eye” and the most recent of which did not request further clinical trials but stated that the “totality of evidence from the completed clinical trials does not support the effectiveness of the product.”

Over the course of the 3 NDA submissions, Aldeyra has provided data from 9 clinical trials, 5 of which achieved all multiplicity-controlled primary endpoints. The company said those results were consistent with or greater than the success rates of clinical trials conducted for approved dry eye disease products. 

According to Aldeyra, the decision to submit the FDRR is based on the outcome of recent Type A and Type D meetings with the FDA Division of Ophthalmology and the Office of Specialty Medicine. Per Prescription Drug User Fee Act target timelines established for the FDRR process, Aldeyra said it expects to hold a meeting with OND in the fourth quarter of 2026. The timing of the OND FDRR decision will depend on a number of factors, including whether the deciding official requests additional information or determines there is a need to discuss the FDRR with internal or external experts or convene an advisory panel, the occurrence and timing of which are uncertain, the company said.